No product has been returned for investigation as product remains in-situ.Radiographs provided confirm a lock screw is not in the fully locked down position.No torque value or device usage confirmed.Unknown if the patient conformed to post-operative activity restriction or suffered a fall.No root cause can be determined as lock screw securing is dependent upon proper rod reduction and torque applied which have not been confirmed.No patient injury reported.Labeling review: ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s) loss of fixation." ".All implants should be used only with the appropriately designated instrument (reference surgical technique)." ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." ".Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques." left in-situ.
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